FDA recall Z-0480-2023

Ethicon, Inc. · Class II · device

Product

PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery

Reason for recall

knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage

Distribution

International (OUS) only: Canada, Japan, Australia and New Zealand

Key facts

Status: Ongoing
Initiation date: 2022-11-16
Report date: 2022-12-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Somerville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0480-2023